Low profile eustachian tube dilation system

Abstract

A system and method for dilating a Eustachian tube of a patient is disclosed. The device includes a protective sheath, a flexible endoscope and a balloon dilation catheter. The protective sheath includes an endoscope lumen and a balloon dilation catheter lumen. The balloon of the balloon dilation catheter is a low profile balloon particularly useful for dilating the Eustachian tube, and in particular, the Eustachian tube of a pediatric patient. The method involves advancing the balloon dilation catheter through a nasal passage of the patient to dilate a portion of the Eustachian tube.

What is claimed is: 
     
       1. A method for dilating a Eustachian tube of a patient, the method comprising:
 advancing a Eustachian Tube Dilation System into a nostril of the patient and through a nasal cavity to position a distal end of the Eustachian Tube Dilation System at, in or near an opening into the Eustachian tube, the Eustachian Tube Dilation System comprising: 
 a protective sheath comprising a flexible elongate shaft, an endoscope lumen and a balloon dilation 
 
       catheter lumen;
 a stiffening member surrounding the flexible elongate shaft of the protective sheath; 
 a flexible endoscope for use in visualizing the Eustachian tube of the patient within said endoscope lumen; 
 a balloon dilation catheter for accessing and treating the Eustachian tube with said balloon dilation catheter lumen, wherein the balloon dilation catheter comprises:
 an elongate shaft, the elongate shaft having a proximal end and a distal end and an inflation lumen therebetween; 
 a low-profile inflatable balloon positioned at the distal end of said elongate shaft; wherein the elongate shaft comprises a hollow shaft extending from the proximal end of the elongate shaft to the inflatable balloon, and a solid shaft extending beyond the inflatable balloon; 
 
 visualizing the nasal cavity, the Eustachian Tube, and the balloon dilation catheter using the flexible endoscope; 
 advancing the balloon of the balloon dilation catheter from the balloon dilation catheter lumen to within the Eustachian tube; 
 inflating the balloon to dilate the Eustachian Tube; 
 deflating the balloon; 
 optionally repeating the inflating and deflating step; 
 withdrawing the balloon into the balloon dilation catheter lumen; and 
 removing the Eustachian Tube Dilation System from the nostril of the patient. 
 
     
     
       2. The method of  claim 1  wherein the hollow shaft comprises a shape memory material. 
     
     
       3. The method of  claim 1  wherein the hollow shaft comprises a polymeric material and wherein the solid shaft further comprises a core wire extending from the elongate shaft proximal end. 
     
     
       4. The method of  claim 3  wherein the core wire has a proximal end and a distal end and the core wire is tapered such that the proximal has a greater diameter than the distal end. 
     
     
       5. The method of  claim 1  wherein the protective sheath further comprises a handle for insertion of the endoscope and the balloon dilation catheter. 
     
     
       6. The method of  claim 5  wherein the handle further comprises a side port for insertion of the balloon dilation catheter. 
     
     
       7. The method of  claim 6  wherein a side port is positioned on the flexible elongate shaft for insertion of the balloon dilation catheter directly into the balloon dilation catheter lumen. 
     
     
       8. The method of  claim 1  wherein the low-profile balloon comprises a balloon with an outside diameter of between 1.0 mm and 1.5 mm when deflated and 2.0 mm and 3.5 mm when inflated.